Clinical Trials Office SOPs

Click on the name of the SOP to view or download the document.


CCCTO SOP Glossary of Common Terms & Definitions Updated 4/10/15 **Working Document**

1.    Administrative SOPs

1.1.   SOP on SOPs v.2.0  **Posted 4/10/15**

1.2.   Change Management SOP v.1.0

1.3.   Organizational SOP

1.4.   Education/Training

1.5.   Notifications

2.     Study Selection

2.1.   Identify Protocols

 2.1.1.     CDA

 2.1.2.     Feasibility

2.2.  Select Protocols

 2.2.1.     Research Manager Review

 2.2.2.     Faculty Disease Committee Review

 2.2.3.     Scientific Review Committee

3.     Study Feasibility

3.1.  Develop/Process Contracts

3.2.  Budget/Logistics Development 

 3.2.1.     Study calendar creation

 3.2.2.     Standard of care/research determinations

 3.2.3.     Pricing

3.3.  Ancillary Committees

3.4.  Gather/Develop Site Documentation

4.     Study Setup

4.1.   Logistic Finalization

4.1.1.       Required protocol training v.2.0**Posted 4/10/15**

4.1.2.      Site initiation visits

4.1.3.      Clinicaltrials.gov submission/updating

4.1.4.      IND Application

4.2.  IRB Submissions

4.2.1.     New submissions

4.2.2.     Emergency Use Protocols

4.2.3.     Compassionate Use Protocols

4.3.  Accounting

4.4   Protocol Implementation Meetings v.2.0

5.     Study Conduct

5.1.   Notification of Study Opening to Enrollment

5.2.   Pre-screening

5.3.   Patient Screening & Enrollment v.2.0 **Posted 4/10/15**

5.4.   Schedule Services

5.5.   Research Billing Management

5.7.  Study Subject Unblinding v.1.0

6.     Ongoing Processes

6.1.  Study Monitors & Monitoring Visits v.3.0 **Posted 4/10/15**

6.2.  Regulatory

6.2.1.   Amendments

6.2.2.   CPRs

6.2.3.   Reportable Events

6.2.4.   External Safety Reports – Industry Sponsored v.1.0 

6.2.5.   External Safety Reports – Cooperative Groups v.1.0

6.2.6.   General

    6.2.6.1.   Uploading study documents in Oncore

    6.2.6.2.   Regulatory document preparation & retention

          6.2.6.2.1.  Completing the 1572 & Financial Disclosures v.2.0 **Posted 4/10/15**

    6.2.6.2.2.  Completing the Delegation of Authority Log v.2.0 **Posted 4/10/15**

                         6.2.6.3.  Investigator Brochure Version Control v.1.0

             6.3. Clinical Research Coordinators

6.3.1.     Randomizing a patient

6.3.2.     Recording patient visits

6.3.3.     Locating Current IRB Approved Protocol Documents

6.3.4. Consenting Study Subjects v.1.0

6.3.5.     Data Entry/CRF Completion

6.4.  Principle Investigators

6.4.1.      Financial disclosures, etc. timelines

6.5. General

6.5.1.     Audit Preparation

6.5.2.     Internal Audits

6.5.3.     External Audits v.1.0

6.5.4.     Planned Study Transition Between CTO Employees v.1.0

6.5.5.     CTO Employee Resignation v.1.0

6.5.6.    Use of Care Everywhere in Epic for Clinical Trials v.1.0

7.     Study Closure

7.1.   Closing a study to enrollment

             7.2.   Notification of Study Closure to Accrual

Clinical Trials Office

Search Active Clinical Trials
 

Adult Cancer Clinical Trials
Medical College of Wisconsin
Cancer Center Clinical Trials Office (CTO)

9200 W. Wisconsin Ave.
Milwaukee, WI 53226

414.805.8900 | Fax: 414.805.0596
cccto@mcw.edu

Pediatric Cancer Clinical Trials
Jennifer Brown
Clinical Research Manager
Pediatric Hematology, Oncology & Transplant
Medial College of Wisconsin
MACC Fund Center for Cancer & Blood Disorders

414.266.8914 | Fax: 414.955.0116
jlbrown@mcw.edu

CTO SOP Distribution List

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E-mail Address

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Medical College of Wisconsin
8701 Watertown Plank Road
Milwaukee, WI 53226
(414) 955-8296
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Page Updated 04/09/2015
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